Effectiveness of a Problem-solving Intervention for Common Adolescent Mental Health Problems in I… (NCT03630471) | Clinical Trial Compass
CompletedNot Applicable
Effectiveness of a Problem-solving Intervention for Common Adolescent Mental Health Problems in India
India250 participantsStarted 2018-08-20
Plain-language summary
We will conduct a two-arm individually randomized controlled trial in six Government-run secondary schools in New Delhi. The targeted sample is 240 adolescents in grades 9-12 with persistent, elevated mental health difficulties and associated impact. Participants will receive either a brief problem-solving intervention delivered by lay counsellors (intervention), or enhanced usual care comprised of problem-solving booklets (control). Self-reported adolescent mental health difficulties and idiographic problems will be assessed at 6 weeks (co-primary outcomes) and again at 12 weeks post-randomization. In addition, adolescent-reported impact of mental health difficulties, perceived stress, mental wellbeing and clinical remission, as well as parent-reported adolescent mental health difficulties and impact scores, will be assessed at 6 and 12 weeks post-randomization. Parallel process evaluation, including estimations of the costs of delivering the interventions, will be conducted.
Who can participate
Age range
13 Years – 20 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Eligibility criteria:
For adolescent participants:
* Enrolled as a student in Grades 9-12 (corresponding to 13-20 years of age)
* Experiencing elevated mental health symptoms, based on response in the borderline or abnormal range (scores of 19 or higher for boys and 20 or higher for girls) on the self-reported SDQ Total Difficulties scale
* Experiencing significant distress and/or functional impairment, based on response in the abnormal range (scores of 2 or higher) on the self-reported SDQ Impact Supplement
* Experiencing difficulties for \>1 month, based on response to the self-reported Chronicity item from the SDQ Impact Supplement
* For adolescents under 18 years of age, able to provide informed assent to participate and supported by parental consent
* For adolescents over 18 years of age, able to provide informed consent to participate
For parent participants:
* A primary parental caregiver or guardian for the index adolescent
* Able to provide informed consent to participate, and if adolescent age 18+ years, parental involvement is supported by the index adolescent
* Proficient in spoken English or Hindi
Exclusion criteria:
For adolescent participants:
* Requiring urgent medical attention (defined as needing emergency treatment or in-patient admission)
* Unable to communicate clearly (due to a speech or hearing disability or inability to comprehend one of the program's languages)
* Already receiving intervention for mental health problems
* Received PRIDE interve…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.